PCSK9 Inhibitors in Acute Ischemic Stroke Patients Undergoing Endovascular Therapy

NCT07174375 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: NFEC-2025-213
• Study Type: interventional
• Target: 478
• Locations: 1 country
• Sites: 12

Brief Summary

This is a prospective, multicenter, randomized controlled clinical study to evaluate the efficacy of PCSK9 inhibitor in addition to standard therapy in patients with acute ischemic stroke undergoing endovascular therapy.

Conditions

Acute Ischemic Stroke

Keywords

acute ischemic stroke; endovascular therapy; PCSK9 inhibitors; Lipid-Lowering Therapy; Early Artery Reocclusion

Outcome Measures

Primary Outcomes (1)

• Functional outcome: The proportion of mordified Rankin Scale of 0 to 2 points

  The proportion of mordified Rankin Scale of 0 to 2 points at 90 days

  90 days after the stroke onset

Secondary Outcomes (11)

• Proportion of patients with early neurological improvement

  7 days post-treatment

• Incidence of target vessel reocclusion or recurrent infarction

  90 days after the stroke onset

• Reduction amplitude of low-density lipoprotein (LDL-C)

  Within 7 days post-treatment

• Mortality rate

  90 days after the stroke onset

• Incidence of symptomatic hemorrhagic transformation

  Within 7 days post-treatment

Study Arms (2)

Standard therapy plus PCSK9 inhibitor

EXPERIMENTAL

Patients in the Standard therapy plus PCSK9 inhibitor group will receive a subcutaneous injection of either Evolocumab (420 mg) or Alirocumab (150 mg) within 48 hours after endovascular therapy, followed by subsequent subcutaneous injections of Evolocumab (420 mg) or Alirocumab (150 mg) every 4 weeks, for a total of 3 administrations.

Drug: PCSK9 inhibitor

Standard therapy alone

NO INTERVENTION

Patients in the Standard therapy alone (control) group will receive standard of care treatment. If low-density lipoprotein cholesterol (LDL-C) levels fail to meet target goals after 7 days, cholesterol absorption inhibitors (e.g., Ezetimibe or Hypemab) may be administered. If LDL-C levels still remain suboptimal after 1 month, PCSK9 inhibitors may be added to the treatment regimen.

Interventions

PCSK9 inhibitor DRUG

PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) inhibitors are a class of monoclonal antibody drugs that lower low-density lipoprotein cholesterol (LDL-C) by inhibiting the PCSK9 protein, which increases the liver's ability to remove LDL-C from the blood. This intervention involves the use of established PCSK9 inhibitor agents.

Also known as: Evolocumab, Alirocumab

Standard therapy plus PCSK9 inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Meets the diagnostic criteria for acute ischemic stroke according to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023.
• Severe stenosis or occlusion of large anterior circulation vessels confirmed by DSA, MRA, or CTA.
• Preoperative NIHSS score ≥ 4 and \< 25.
• Meets the indications for endovascular therapy per the Chinese Guidelines for Endovascular Therapy of Acute Ischemic Stroke 2023, and successful reperfusion of the target vessel (mTICI ≥ 2b) achieved via emergency endovascular intervention.
• LDL-C \> 1.8 mmol/L or non-HDL cholesterol \> 2.6 mmol/L.
• Signed informed consent provided by the patient or their legally authorized representative.

You may not qualify if:

• Confirmed non-atherosclerotic causes of vascular stenosis/occlusion (e.g., cardioembolism, vasculitis, vascular malformation, moyamoya disease, iatrogenic causes).
• History of intracranial hemorrhage or systemic bleeding within the past 3 months.
• Presence of hemorrhagic transformation (PH1/PH2) immediately after the procedure.
• Severe hepatic impairment: ALT \> 3 times the upper limit of normal, INR \> 1.2, hepatic encephalopathy, or history of drug-induced liver injury.
• Use of PCSK9 inhibitors within 6 months prior to enrollment.
• Pre-stroke mRS ≥ 2.
• Terminal illness (e.g., malignancy, end-stage renal disease) with an expected survival of \< 3 months.
• Pregnancy or lactation.
• Other neurological diseases that may interfere with neurological function assessment during follow-up.
• Allergy or intolerance to PCSK9 inhibitors or statins.
• Participation in another interventional clinical trial.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (12)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Location

Dongguan Donghua Hospital

Dongguan, Guangdong, China

Location

Dongguan People's Hospital

Dongguan, Guangdong, China

Location

Huadu District People's Hospital of Guangzhou

Guangzhou, Guangdong, China

Location

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

Heyuan People's Hospital

Heyuan, Guangdong, China

Location

Hengzhou City People's Hospital, Guangxi

Hengzhou, Guangxi (Autonomous Region), China

Location

Hainan Provincial Hospital of Traditional Chinese Medicine

Haikou, Hainan, 570100, China

Location

Haikou People's Hospital

Haikou, Hainan, China

Location

Hainan Provincial People's Hospital

Haikou, Hainan, China

Location

The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

Location

Ganzhou City People's Hospital

Ganzhou, Jiangxi, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

evolocumab; alirocumab

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Kaibin Huang, Ph.D.

CONTACT

+8615915751065; hkb@smu.edu.cn

Suyue Pan, Ph.D.

CONTACT

+86 02062787648; pansuyue@smu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 15, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (12)